NCT04226196

Brief Summary

The present study should investigate the influence of a capsular tension ring on postoperative rotational stability of a plate haptic hydrophilic acrylic intraocular lens. All patients will be operated on both eyes in one occasion. Both eyes receive a Zeiss 409MP plate haptic intraocular lens, while only on eye receives an additional capsular tension ring. Follow up visits take place 1 hour, 1 week, 1 month and 4 to 7 months after surgery. At the follow up visits, the actual IOL axis will be determined by retroillumination photography. IOL centration and tilt will be determined by anterior segment SS-OCT Casia II. IOLs will be implanted in 4 different axis 0 +/- 10 degrees, 45 +/- 10 degrees, 90 +/- 10 degrees, 135 +/- 10 degrees. IOL rotation, decentration and tilt then will be compared intraindividually.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

January 9, 2020

Last Update Submit

April 13, 2020

Conditions

Intraocular Lens RotationCapsular Tension Ring

Keywords

Intraocular lens rotationcapsular tension ringpostoperative tilt & decentration

Outcome Measures

Primary Outcomes (1)

  • Change of axial intraocular lens position

    Change in axis position of an intraocular lens Zeiss 409 MP from end of surgery (baseline axis) to 1 hour, 1 week, 1 month and 4-7 months (end of study visit). The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)

    7 months

Secondary Outcomes (4)

  • Decentration

    7 months

  • Tilt

    7 months

  • Anterior chamber depth

    7 months

  • Best corrected visual acuity (BCVA)

    7 months

Study Arms (4)

Axis 0

EXPERIMENTAL

IOL Implantation at the 0 +/- 10 degrees axis

Device: Implantation of an intraocular lens

Axis 45

EXPERIMENTAL

IOL Implantation at the 45 +/- 10 degrees axis

Device: Implantation of an intraocular lens

Axis 90

EXPERIMENTAL

IOL Implantation at the 90 +/- 10 degrees axis

Device: Implantation of an intraocular lens

Axis 135

EXPERIMENTAL

IOL Implantation at the 135 +/- 10 degrees axis

Device: Implantation of an intraocular lens

Interventions

Implantation of an intraocular lensDEVICE

Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.

Axis 0Axis 135Axis 45Axis 90

Eligibility Criteria

Age45 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
  • Need for spherical IOL correction between +0.00 and +32.00 D
  • Pupil dilation of ≥ 7.0 mm
  • Age 45 to 95

You may not qualify if:

  • Corneal abnormality (Corneal scaring)
  • Preceding ocular surgery or trauma
  • Uncontrolled glaucoma
  • Proliferative diabetic retinopathy
  • Iris neovascularization
  • History of uveitis/iritis
  • Microphthalmus
  • Recurrent intraocular inflammation of unknown etiology Uncontrolled systemic or ocular disease
  • Pregnancy
  • Lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna Allgemeines Krankenhaus

Vienna, 1090, Austria

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigator will be masked to which axis the IOL will be implanted until a sealed envelope will be opened in the operating theater.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ao. Univ. Prof. Dr.

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 13, 2020

Study Start

January 27, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

AU(1)